临床研究助理（CRA）

When our values align, there's no limit to what we can achieve.

At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
Working with heart
At the end of the day we’re all patients. Because of this, the Parexel team takes our work personally and does it with empathy and heart. When our values align, there’s no limit to what we can achieve. Our clinical operating model drives effectiveness, reduces handoffs and increases employee, client and site satisfaction. As a Clinical Research Associate at Parexel, you will be joining a team with a wide variety of experiences and knowledge. We hire talent that takes initiative to do things better, smarter and faster- people who want to grow personally and professionally.

Your time here
At Parexel, the CRA role offers the opportunity to go beyond the role of a typical clinical monitor. CRA’s are accountable for using their expertise to build and maintain the site relationship and ensure they are set up for success. As the clinical sites’ sole point of contact, this includes addressing and resolving site issues and questions. You will also manage site quality and delivery from site identification through to close-out.

As a CRA, Parexel will offer you world class technology and training catered to your individual experience. You can anticipate less travel and a lower protocol load in comparison to industry peers. Your hard work may be rewarded through a bonus incentive program, the opportunity to work within multiple therapeutic areas and an opportunity to advance your career in clinical research. If impact, flexibility, and career development appeal to you, Parexel may be your next home.

What you’ll do

• Leverage your expertise. Conduct qualification visits (QV), site initiation visits (SIV), monitoring visits (MV) and termination visits (TV) at assigned clinical sites and generate visit/contact reports.

• Build relationships. Oversee integrity of the study and utilize problem-solving skills to promote rapport with the site and staff.

• Protect patients. Review the performance of the trial at designated sites, ensure the rights and well-being of human subjects are safeguarded and are in accordance with protocol.

• Drive productivity. Develop patient recruitment strategies in conjunction with the clinical site to meet enrollment timelines while also Ensuring compliance with the approved standard operating procedures (SOPs), protocol/amendment(s), GCP, and the applicable regulatory requirement(s).

• Ensure quality. Evaluate the quality and integrity of the reported data, site efficacy and drug accountability.

• Execute. Monitor completeness and quality of Regulatory Documentation and perform site document verification.

A little about us
Parexel is proud to be a leading Clinical Research Organization with team members across the globe. As a member of our team, you will get to know your colleagues on a personal level. Have a question? A clinical research leader, project team member, technology “super user” or colleague are a phone call away. Our clinical research teams meet regularly to have discussions in an open environment, allowing our team members to share their expertise and promote learning within the team. Management supports and encourages career growth through consistent performance discussions and evaluations. Whether your interest is to progress into a more senior level CRA role, into line management, Quality, Project Leadership or a variety of other positions, Parexel prides itself on career opportunities for our employees.

More about you
On your first day we’ll expect you to have:

• 18+ months of direct onsite monitoring experience as a Clinical Research Associate (CRA)

• Bachelors or equivalent degree in biological science, pharmacy or other health related discipline.

• Strong interpersonal, written, and verbal communication skills within a matrixed team.

• Ability to work in a self-driven capacity with a sense of urgency and limited need for oversight.

• A client focused approach to work with a flexible attitude with respect to assignments and new learning.

• The ability to manage multiple tasks, evaluate a variety of unpredictable scenarios and achieve project timelines while being able to apply your understanding of study protocol(s).

• An honest and ethical work approach to promote the development of life changing treatments for patients.

• Strong computer skills, including but not limited to the knowledge of a Clinical Trial Management System (CTMS), Electronic Document Management System (EDMS) and MS-Office products such as Excel and Word.

Originally posted on Himalayas